Introduction

The 12th edition of Standards for Cellular Therapy Services (CT Standards) was prepared by the Cellular Therapies Standards Committee (CT SC) and the Standards Program Committee of the AABB. The goal of the CT Standards is to maintain and enhance the quality and safety of the procurement, processing, storage, and clinical administration of cellular therapy products and to provide a basis for the Accreditation Program of the AABB. The following frequently asked questions will help users of this book better understand this 12th edition of CT Standards:

When does this edition go into effect?
The effective date of this edition is July 1, 2025.

Are the CT Standards requirements or recommendations?
The CT Standards contains requirements implemented by AABB accredited cellular therapy laboratories. A requirement contains the word “shall,” which indicates that the statement is mandatory. Failure to meet the requirement would constitute a nonconformance under the AABB Accreditation Program. There are rare instances in which a standard uses the term “may.” A statement that uses “may” is not a requirement.

How does this book relate to other laws and regulations?
The CT Standards were developed on the basis of good medical practice and, when available, scientific and evidence-based data. The requirements in this book can be followed by a cellular therapy facility located anywhere in the world, but they do not preempt federal, state, and/or local laws and regulations. Accredited facilities must follow the CT Standards as written to ensure continued AABB accreditation in good standing. Although the majority of the standards here are intended to be consistent with these applicable laws and requirements, no assurances can be given that compliance with CT Standards will result in compliance with all applicable laws and requirements. These CT Standards are not intended as a substitute for legal advice, and the content should not be relied upon for legal purposes. Therefore, users must make their own determinations as to how best to ensure compliance with all applicable laws and requirements, including consulting legal counsel familiar with these issues.

Does this edition require me to follow my own local laws and regulations?
Yes. In many standards, the CT SC chose to use the term “specified requirements.” This phrase is defined in the glossary to include any applicable requirement under which a service might operate. These could include, but are not limited to, a federal regulation, a customer
agreement, a practice standard, the instructions for the intended use of a device, or a requirement of an accrediting organization.

What does the pen symbol mean?
When the pen symbol precedes a standard, users have to maintain a record of that activity in order to meet the standard. Readers should refer to the record retention tables at the end of each chapter and the comprehensive reference standard at the end of Chapter 6 to determine
what that record must contain, as well as the required record retention time.

What do the “C” and “F” next to the pen symbol mean?
The “C” designation means that the record retention period follows the creation of the cellular therapy product associated with the record. The “F” designation means that the record retention period follows the final disposition of the cellular therapy product associated with the
record.

What other tools are available to help me implement the CT Standards?
There are several other resources to assist users. This publication also includes:

A glossary, which reflects the usage of specific words or phrases in the context of these CT Standards.
A crosswalk that cross-references the standards in this edition of CT Standards with those in the previous edition.

In addition, users of this edition may also want to:

Visit the AABB website for a document that details the significant changes to this edition. This document is titled “Significant Changes and Response to Comments” to the 12th edition.
Follow guidance to the 12th edition of CT Standards, found in the AABB Standards Portal online, or in the printed Guidance for Standards for Cellular Therapy Services. The guidance provides rationales behind significant changes to this edition of CT Standards and provides recommendations on how to meet the intent of certain standards.
Contact the Standards Department to ask for interpretations or to submit a variance request. Variances to standards are effective for the edition of CT Standards for which they are received. Request forms for variances can be found on the AABB website.
Requests for renewal of previously granted variance requests must be submitted prior to the effective date.